Devices for treatment of viral infections

ABSTRACT

A device for treating viral infections. Embodiments of the device can include a housing, a power supply component disposed inside the housing, an electrical signal source, and a disposable head for connecting with the housing in a detachable manner. The disposable head can comprise an application surface for application to the skin or mucosa of a patient, and at least two embedded electrodes adapted for respectively connecting with the at least two output terminals of the electrical signal source. The device may include at least four embedded electrodes. The electrical signal source generates electrical pulses, and these electrical pulses are applied to the patient through the embedded electrodes of the disposable head.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a method and apparatus for deliveringelectrical neuromodulation stimulation to pathological tissue, and moreparticularly, to treating viral infections by applying a series ofelectrical pulses having different maximum amplitudes and/or differentfrequencies to the affected skin or mucosa.

2. Description of the Related Art

Viruses are the smallest infectious agents and contain a molecule ofnucleic acid (RNA or DNA) as their genome. Nucleic acid is enclosed in aprotein shell. The viral nucleic acid contains information necessary forprogramming the infected host cell to synthesize specific number ofmacromolecules. Toward the end of the replication cycle, more viralnucleic acids and coat proteins are produced. The coat proteins assembletogether to form the symmetrical protein shell, which encloses thenucleic acid genome.

Herpes Viruses: There are eight identified herpes viruses that have beenassociated with human disease conditions. The alpha-herpes viruses,HSV-1, HSV-2, and VZV-2, known as oral herpes, genital herpes, andherpes zoster respectively, are neurotropic since they actively infectnervous tissue. Five other herpes viruses are lymphotropic since theyreplicate in the lymphatic system. These include HCMV (humancytomegalovirus), HHV-6, HHV-7, HHV-8 (KHSV) and EBV. HHV-6 has beenassociated with multiple sclerosis. HHV-8 (KHSV) and EBV have beenlinked to the human cancers Kaposi's sarcoma and Epstein-Barr disease.

Disease states are also caused by a variety of other viruses. Viralhepatitus is a serious liver disease of particular concern forhealthcare professionals. One form of hepatitus, hepatitus C, isconsidered responsible for approximately 10,000 deaths per year. Thehuman papilomavirus (HPV) is responsible for most of the cervicalcancers worldwide, genital warts and the formation of verrucae, wartsthat form on the soles of the feet. HPV has also been associated withseveral oral cancers. In addition, the HIV virus has killed more than 19million people and infected 34 million, causing an epidemic that willcontinue to devastate communities around the world.

Herpes Viruses Associated with Human Disease Conditions Oral Herpes: TheHSV-1 Virus

Herpes simplex virus (HSV) infections of the oral tissues are among themost common infectious illnesses involving man. Both primary (initial)and recurrent forms of the infection occur, these being referred to asacute primary herpetic gingivo stomatitis, and recurrent oral herpes.Although oral herpes infections may be considered primarily nuisancediseases, gingivostomatitis can be a very painful and debilitatingillness, while recurrent oral herpes in immunosuppressed subjects may besevere and even life-threatening (Overall, 1979; Ho, 1979; Faden et al,1977).

The vast majority of oral herpes infections are caused by the HSV type 1strain. There are no precise data for the frequency of oral herpesinfections although it is estimated that there are about 500,000 casesof oral herpes each year in the U.S. Recurrent oral herpes occurs inapproximately one-third of the population and the mean number ofepisodes per year in individuals with recurrent disease is 1.6 (Overall,1979). This projects at about 100 million episodes of oral herpes in theU.S. each year and a similar prevalence occurs worldwide.

There are several factors that contribute to the significance of oralherpes infections. First, herpes gingivostomatitis can be a severeillness. Fever, toxicity, and exquisitely painful mouth lesions mayinterfere with fluid intake and require hospitalization for intravenousfluids. Second, frequent recurrent lesions of the lips are of cosmeticconcern, particularly in females. Third, cold sores may be the source ofHSV for transmission to immunosuppressed or other hospitalized patients.Fourth, oral herpes in the immunosuppressed patient is often a severe,life-threatening disease. Finally, there is currently no satisfactoryand effective form of therapy for either primary or recurrentmucocutaneous HSV disease in the normal host.

Most patients develop vesicles within 12 hours, which rupture to formulcers or crusts in 36 to 48 hours. Most patients lose the crust andhave healed ulcers by day 8 to 14. Results from clinical trials onrecurrent oral herpes has shown that about 25% of patients had episodesone or more times a month, almost two-thirds had one episode every 2-4months, and less than 25% had an episode less often than every 4 months(Spraunce et al, 1977).

Genital Herpes: The HSV-2 Virus

Despite the emphasis and publicity on safe sex to prevent AIDS, a recentstudy by the Centers for Disease Control has shown that genital herpeshas increased fivefold among teenagers since the late 1970's, anddoubled among 20 year olds (New Eng. J of Medicine, Oct. 16, 1997). Onein five Americans over the age of 12 years carries the virus that causesgenital herpes, with 500,000 new cases occurring each year.

It is currently standard practice in the U.S. to perform Cesareandelivery on pregnant women with recurrent herpes to reduce the risk oftransmission of the virus to newborns (J. Obstetrics & Gynecology,October 1996). In spite of this, 20-30% of all infants born via Cesareandelivery still have the herpes virus, a condition called neonatalherpes. More than 40% of newborns infected with HSV die or sufferneurologic impairment. What makes this problem worse is that women are45% more likely to be infected with HSV-2 than men. Since there has beena dramatic increase in genital herpes among the younger generations, itmeans that a substantial number of women entering their childbearingyears are infected with HSV-2, or are at risk of contracting infection.Despite antiviral therapy, neonatal herpes is still a major lifethreatening infection.

After inoculation and limited replication at genital sites, HSV-2ascends along neuronal axons to establish latent infection in thelumbosacral ganglia. During this initial phase, infectious virus ispresent at genital sites for days or weeks, usually without lesions.When a new cycle of viral replication is triggered, reactivation occursand infectious virus is delivered back down the neural pathways to themucosa or skin. The return of infectious virus to genital sites duringHSV-2 reactivation rarely causes any symptoms. HSV-2 is a chronic,persistent infection that causes subclinical reaction in about 1% ofinfected persons. Since about 45-50 million people in the U.S. areinfected, HSV-2 can spread efficiently and silently through thepopulation. People who have sexual contact with many partners willfrequently have exposure to an infected person who is shedding HSV-2. Asthe overall prevalence of HSV-2 infection continues to rise, contactwith fewer partners will permit exposure.

The concept that HSV persists in the nuclei of cells in the sensoryganglia suggests that any topical treatment will be ineffective indestroying the virus in these hidden locations. About 25 viruses havebeen placed in the HSV group and they all contain a core of doublestranded DNA surrounded by a protein coat that exhibits isocahedrilsymmetry. This in turn is enclosed in an envelope, which containsessential lipids. The structural proteins of herpes simplex virusinclude nine polypeptides, which have been found in the envelopedvirion, two polypeptides which are associated with the envelope, twoarginine polypeptides within the virus core, as well as guanine andcytosine. The virus enters the cell either by fusion with the cellmembrane or by pinocytosis. It is then uncoated and the DNA becomesassociated with the nucleus. Soon after infection the virus codes forits own DNA polymerase and other enzymes such as thymidine kinase whichis associated with the DNA replication.

A variety of treatments have been used for genital herpes but none isentirely satisfactory. No satisfactory vaccine has been found. Insuperficial infections, topical agents such as Idoxuridine,Triflurothymidine, or Acyclovir are sometimes effective. The drug ofchoice for the treatment of herpes simplex is Acyclovir, which is theonly FDA approved drug. Sales of Zovirax® (Burroughs Wellcome) arestated at about $500M. Annual estimated sales for this product exceeded$2 billion worldwide in 1997. Administered orally for systemicabsorption, Acyclovir is limited by several factors:

-   -   1) side effects include rash, nausea, vomiting, diarrhea, or        pain, burning or itching at the site where the drug is applied,        anorexia and possible eye injures.    -   2) cost; the average annual cost to a patient is around $1000.    -   3) emergence of drug-resistant virus strains.    -   4) presence of a large number of “early reactivation” patients        for whom Acyclovir does not work.    -   5) a 6-10 day treatment cycle; patients with HSV-1 (oral        herpes/cold sores) must decide if treatment is worth 6-10 days        use of an expensive systemic drug with potential adverse side        effects.

First episodes of the virus should be treated as early as possible withone of three available oral antiviral agents, all of which are based onAcyclovir. Recommended treatments include: Acyclovir (Zovirax™) wherethe usual dose is 200 mg five times daily. Valacyclovir HCl (Valtrex™)is an improved oral formulation of Acyclovir which requires lessfrequent dosing at 500 mg twice daily. Famciclovir (Famvir™) is the oralformulation of penciclovir and it is dosed for primary infections at 250mg three times daily. Studies have proven all three drugs to be equallyeffective. In North America, first episode treatment is generallyprescribed for 10 days, but in Europe and the UK, treatment is generallyprescribed for 5 days. These antiviral medications can be taken orallyvery early in a recurrent episode.

Herpes Zoster

Herpes zoster, also known as shingles, is due to invasion of posteriorroot ganglia by the causative virus and is characterized by severe painfollowed by a rash over cutaneous distribution of the affected nerve.The virus, varicella-zoster (VZ), causes two diseases, varicella(chickenpox) resulting from the first exposure to the virus inchildhood, and zoster, a secondary infection due to reactivation of thelatent VZ virus. Shingles is a painful and potentially debilitatingdisease that affects 750,000 people each year in the U.S. alone. Thecondition is most commonly experienced by older people and is caused bya reactivation of the varicella-zoster virus, usually as a result oftrauma such as hitting ones head on a cabinet door in the kitchen. Theis same herpes virus which causes chickenpox in the young. A majorchallenge for physicians in managing patients with shingles isalleviating the severe pain associated with an active shingles rash, aswell as post herpetic neuralgia (long-term debilitating pain) which mayoccur following rash healing and which can last for many years.

Herpes and Multiple Sclerosis

A strain of reactivated herpes virus may be associated with multiplesclerosis (MS), an autoimmune disorder in which the body attacks its owntissues. Results of a study conducted by scientists at the NationalInstitute of Neurological Disorders and Stroke (NINDS) in Bethesda, Md.,in the U.S. adds to mounting evidence of the role of viral triggers inMS. This is the first published large-scale study suggesting anassociation of a human herpes virus in the disease process of MS. In thestudy, more than 70 percent of patients with the relapsing-remittingform of MS showed an increased immune response to human herpes virus-6(HHV-6) and approximately 35 percent of all MS patients studied haddetectable levels of active HHV-6 in their serum. Scientists believethat there may be a point in time during the progression of MS when thevirus, which lies dormant in the body for years, reactivates, accountingfor its presence in a subset of MS patients. The study first appeared inthe December 1997 issue of Nature Medicine.

As many as 350,000 Americans are affected by MS, which is most oftendiagnosed in patients between the ages of 20 and 40 and is characterizedby muscle weakness, visual disturbances, and a variety of otherneurological impairments. The array and severity of symptoms varieswidely from patient to patient and women are more likely to be affectedthan men. The most common form of MS is the relapsing-remitting type. Inthis type of MS, new symptoms appear or existing ones become moresevere, followed by periods of partial or total recovery. Theseflare-ups of new or intensified symptoms last for variable amounts oftime. A second form of MS is a chronic and progressive one in whichsymptoms steadily worsen. HHV-6 is relatively new to scientists and isknown to cause a common childhood illness, Roseola. HHV-6 is known to bepresent in 90 percent of the adult American population as a result ofinfection during the first few years of life. Scientists believe thatthe reactivation of HHV-6 virus may be associated with the breakdown ofthe protective covering of nerves, called myelin. Reactivation ischaracteristic of herpes viruses. In the study, investigators screenedthe serum of 102 individuals, 36 of whom had MS. Of the 22 individualswith the relapsing-remitting form of MS, 73 percent had an increase inimmune response to an early antigen of HHV-6, compared to only 18percent of those participants who served as normal volunteers. Inaddition, the scientists detected HHV-6 DNA in the serum (a marker ofactive virus infection) of 15 of 50 individuals with MS. All 47individuals without MS tested negative for the presence of active HHV-6viral infection.

Human Papillomavirus

Human papillomavirus (HPV) is one of the most common sexuallytransmitted diseases. Genital HPV infections are widespread amongsexually active adults. It is estimated that as many as 40 millionAmericans are infected with HPV, and the incidence of the diseaseappears to be increasing. More than 1000 types of HPV have beenidentified. Some cause common skin warts. Others are spread throughsexual contact and result in genital warts.

HPV often results in an infection without any visible symptoms. Thus,individuals may not be aware of the infection or of the potential riskof transmission to others. Genital warts are spread by sexual contactand are highly contagious. Approximately two-thirds of people who havesexual contact with a partner with genital warts will develop warts,usually within about three months of contact.

In women, the warts occur on the outside and inside of the vagina, onthe cervix, and around the anus. In men, the warts occur on the penis,scrotum, and around the anus. Genital warts often occur in clusters, andcan be very tiny or can occur in large masses. Treatment includes theapplication of trichloracetic acid or podophyllin solution. Warts can beremoved by cryosurgery, electrocautery or surgery. Although eliminationof the warts is possible, the viral infection persists and warts oftenreappear after treatment.

To date, there are very few satisfactory treatments, vaccines, or curesfor viral infection. Drug treatments, either topical or ingested, haveshown generally limited benefits. As an alternative to thepharmaceutical approach, the electrical meuromodulation stimulation ofinfected tissues has been explored. These methods involve theapplication of electrodes to the skin near the infected region. Someexamples are provided by U.S. Pat. No. 4,913,148 to Diethelm, U.S. Pat.No. 5,133,352 to Lathrop, et al., and U.S. Pat. No. 5,607,461 toLathrop. The disclosures of each of these patents is hereby incorporatedby reference in their entireties. Although this technique shows promise,to date, the devices and stimulation protocols used have been lesssuccessful at eliminating viral infection than was hoped.

SUMMARY OF CERTAIN EMBODIMENTS

The system, method, and devices of the invention each have severalaspects, no single one of which is solely responsible for its desirableattributes. Without limiting the scope of this invention, its moreprominent features will now be discussed briefly. After considering thisdiscussion, and particularly after reading the section entitled“Detailed Description of Certain Embodiments” one will understand howthe features of this invention provide advantages that include allowinga disposable head to be attached to an electrical signal source fortreating viral infections.

In one embodiment, a device for treating viral infections includes ahousing, a power supply component disposed in the housing, and anelectrical signal source disposed in the housing. The signal sourcecomprises at least two output terminals, and is configured for producinga series of electrical pulses on the at least two output terminals.Power is supplied from the power supply component to the electricalsignal source. The device can also comprise a disposable head adaptedfor connecting with the housing in a detachable manner, disposable headcomprising at least two embedded electrodes adapted for respectivelyconnecting with the at least two output terminals of the electricalsignal source, subsequent to the disposable head being connected withthe housing.

In another embodiment, a disposable head includes an application surfaceon a first side of the disposable head, for application to the skin ormucosa of a patient, and at least two embedded electrodes adapted forconnecting with an electrical signal source under a condition that thedisposable head is attached to the electrical signal source in adetachable manner. The at least two embedded electrodes include anexposed surface on the application surface, forming at least two exposedsurfaces of the at least two embedded electrodes, each of the at leasttwo exposed surfaces being separated from one another by an insulatingmaterial.

In another embodiment, a method of treating viral infections includesattaching a disposable head to a housing of an electrical signal sourceso that at least two electrodes embedded within the disposable headrespectively connect with at least two output terminals of theelectrical signal source, placing an application surface of thedisposable head in proximate of or in contact with the skin or mucosa ofa patient; generating a series of electrical pulses by the electricalsignal source, and applying the series of electrical pulses to the skinor mucosa of the patient through the at least two electrodes, whereineach of the at least two electrodes comprises an exposed surface on theapplication surface of the disposable head.

In another embodiment, the disposable head includes at least fourembedded electrodes. In certain embodiments, a battery compartment isprovided within the housing such that the electrical signal source canbe powered by at least one battery. A plurality of disposable heads canalso be provided in a cartridge so that a user can conveniently attach anew disposable head from the cartridge to the housing of the device. Infurther embodiments, the disposable head comprises a circularapplication surface for application to skin or mucosa such as the lips.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of one embodiment of an electricalneuromodulation stimulation device.

FIG. 1B is a plan view of an exemplary electrode configuration of thedevice illustrated in FIG. 1A showing

FIG. 1C is a plan view of three other exemplary electrode configurationsof the device illustrated in FIG. 1A.

FIG. 2A is a block diagram of an electrical circuit, which can beprovided in certain embodiments of a neuromodulation stimulation device.

FIG. 2B is a block diagram of another electrical circuit, which can beprovided in certain embodiments of a neuromodulation stimulation device.

FIG. 3 is a perspective view of an embodiment of an electricalneuromodulation stimulation device.

FIG. 4 is a perspective view of another embodiment of an electricalneuromodulation stimulation device.

FIG. 5A is a side view of another embodiment of the electricalneuromodulation stimulation device, showing a removable activatorinserted into the housing of the device.

FIG. 5B is a side view of the embodiment of the electricalneuromodulation stimulation device illustrated in FIG. 5A, showing anembodiment of a removable activator removed from the device.

FIG. 5C is an end view of the distal end of the device illustrated inFIGS. 5A and 5B, showing an embodiment of the electrode configuration.

FIG. 6A is a side views of another embodiment of an electricalneuromodulation stimulation device, showing an embodiment of a removableactivator inserted into the housing.

FIG. 6B is side view of the embodiment of the electrical neuromodulationstimulation device illustrated in FIG. 5A, showing the removableactivator and removed from the housing.

FIG. 6C is an end view of the distal end of the device of FIGS. 6A and6B, showing an embodiment of the electrode configuration.

FIG. 7 is a perspective view of an embodiment of an neuromodulationstimulation device configured to accept disposable electrode treatmentheads.

FIG. 8A is a perspective view of an embodiment of a disposable electrodehead that attaches to housing of the electrical treatment deviceillustrated in FIG. 7.

FIG. 8B is a side view of the base of the disposable electrode headillustrated in FIG. 8A.

FIG. 9 is a flow chart of a method for treating viral infections.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

Embodiments of the invention will now be described with reference to theaccompanying Figures, wherein like numerals refer to like elementsthroughout. The terminology used in the description presented herein isnot intended to be interpreted in any limited or restrictive manner,simply because it is being utilized in conjunction with a detaileddescription of certain specific embodiments of the invention.Furthermore, embodiments of the invention may include several novelfeatures, no single one of which is solely responsible for its desirableattributes or which is essential to practicing the inventions hereindescribed.

Referring now to FIG. 1A, there is shown one embodiment of theelectrical neuromodulation stimulation device of the present invention,useful for treating viral infections. The device 10 includes a housing12, which is designed to fit comfortably in the hand of the user. At oneend, two electrodes 18 a and 18 b are mounted. Such an end is referredto as “application surface.” The application surface can include asurface upon which electrodes are disposed such that the surface and theelectrodes can be placed against the skin of a patient for treatment. Insome embodiments, the application surface does not include a physical“surface” but instead refers to a planar portion of the end of theneuromodulation stimulation device, or a disposable head, whereelectrodes are disposed.

The electrodes 18 a, and 18 b have an elongated surface for applicationto the user's skin. The elongated electrodes allow for larger electrodeto skin surface contact. As shown in FIG. 1A, each electrode 18 a, 18 bmay comprise a closed contour. In some embodiments, the electrodes 18 a,18 b are concentric closed contours. In the embodiment of FIG. 1A, theelectrodes comprise circuit traces plated onto a printed circuit board19 that is attached to one end of the housing 12.

It will be appreciated that the electrodes may take many forms andshapes. The electrodes 18 a and 18 b can be oval or elliptical as shownin FIG. 1A, rectangular as shown in FIG. 3, or circular as shown FIG. 4.The electrodes may also be square, or any other desired shapes. Theelectrodes can comprise highly conductive material, and are preferablygold plated. However, any electrically conductive material can be used.An on/off button or switch 20 that is manually operated is located onthe housing 12. The device 10 can include a first LED 22 that isactivated when the device is turned on. The device 10 can also include asecond LED 23 that indicates a low battery condition. However, the firstLED 22 and the second LED 23 are optional and in some embodiments, thefirst LED 22 and/or the second LED 23 are not included. An alphanumericdisplay 25 may also be provided on the device 10 to provide the userwith a variety of information concerning device and/or treatment status.An example of such information is a count of the number of times anelectrical signal source has energized the electrodes, which willdescribed below.

In operation, the electrodes 18 a and 18 b are placed in close proximityto, or preferably in contact with, the patient's skin or mucosa. Whenenergized, the device 10 can deliver electrical energy to the electrodes18 a and 18 b in a variety of treatment applications. Described inadditional detail below, the device can be configured to provide varioustreatment protocols, including applying a series of electrical pulses tothe affected area. The display 25 may exhibit a count of the number oftreatments applied, thus indicating to the user at any given time howmuch of the treatment protocol has been completed.

The device as illustrated in FIG. 1A may comprises more than twoelectrodes exposed on the application surface. FIG. 1B is an example ofan end view of the device as illustrated in FIG. 1A, and illustratesfour electrode traces 18 a, 18 b, 18 c, 18 d on the circuit board 19 atone end of the housing 12, i.e., on the application surface. That is,the electrode traces (or boundaries) exposed on the application surfaceare not limited in number.

FIG. 1C illustrates other examples of an end view of the device 10 asillustrated in FIG. 1A. Pattern 8 in FIG. 1C illustrates a configurationof the electrode traces (or boundaries) in an oval shape. Pattern 9 inFIG. 1C illustrates a configuration of the electrode traces in arectangular shape. Pattern 6 in FIG. 1C illustrates a configuration ofelectrodes of device 10 with two electrodes exposed on the applicationsurface. Each of the two electrodes in pattern 6 is configured in asubstantially semicircular shape on the circuit board 19 (FIG. 1A). Thetwo semicircular electrodes can be separated from each other by aninsulating layer 7 which can also formed on the circuit board 19. Theinsulating layer 7 can comprise any insulating material.

Other forms, shapes and numbers of electrodes can also be provided onthe application surface of the device as illustrated in FIG. 1A. Forsimplicity and conciseness, however, they are not illustrated anddescribed in detail.

FIG. 2A illustrates circuitry provided inside the housing 12 in someembodiments of the invention. The device will generally include a powersupply component, such as a battery 16, which may be rechargeable ordisposable, coupled to a logic/processor circuit 14, a signal generatorcircuit 17, and the display 25. The logic/processor circuit 14 drivesthe display 25 and configures the signal generator circuit 17 to outputthe desired electrical signal to the electrodes 18 a and 18 b. Althoughshown as separate blocks in FIG. 2A, it will be appreciated that thelogic/processor circuit 14 and the signal generator circuit 17 may befunctionally combined, and will typically reside on a common printedcircuit board in the housing 12. The types of signals produced by thesignal generator circuit 17 in embodiments of the invention will bedescribed in additional detail below. In some other embodiments, thepower supply component comprises an AC/DC convener which is adapted forreceiving an alternate current from outside of the housing 12 andconvening the alternate current into a direct current. The power supplycomponent may also comprises an input terminal that is adapted forreceiving power (e.g., DC input) from outside of the housing 12.

The number of the electrodes 18 a, 18 b (FIG. 2A) is not limited to two.FIG. 2B illustrates an embodiment where the signal generator 17 isconnected to four electrodes 18 a, 18 b, 18 c and 18 d. In otherembodiments, more than four electrodes can be used.

The physical size and shape of the device will advantageously varydepending on the specific intended application. The embodimentillustrated in FIG. 1A, for example, is advantageously sized for use onthe legs and genital area. In this embodiment, the electricalneuromodulation stimulation device 10 is approximately 2-4 inches long,approximately 1-1.5 inches wide, and approximately 0.5-1 inches deep. Asnoted above, the device 10 is sized so as to fit comfortably in the handof the user. The circuit traces forming the concentric electrodes 18 a,18 b shown in FIG. 1A, are approximately 2-3 mm in width, and are platedto a thickness of less than 1 mm.

FIG. 3 is a perspective view of another embodiment of an electricalneuromodulation stimulation device for treatment of the genital area. Asillustrated in FIG. 3, the end (i.e., application surface) of the device10, which mounts the electrodes, or exposes the electrodes, is curved sothat it is easier to produce contact between the skin of the patient andthe entire electrode surface.

FIG. 4 is a perspective view of another embodiment of an electricalneuromodulation stimulation device, which is an oral applicator. Asillustrated in FIG. 4, the device 10 includes a housing 12 andconcentric electrodes 18 a and 18 b at the applications surface, the topend of the device 10. In this embodiment the electrodes 18 a and 18 bare circular, and the center electrode 18 b forms a circular pad ratherthan a ring. This embodiment can be for oral application, andadvantageously measures about 0.5 to 0.75 inches in diameter with alength of about 2-4 inches. This is a similar size and shape of alipstick or lip balm applicator, and thus is very convenient forcarrying in a pocket or purse. In this embodiment, the display 25 may beprovided on the bottom flat surface opposite the electrode surface or onthe side of the device 10 in a convenient position so that the patientcan view LED information while carrying out treatment of an oral lesionwhile using a mirror. A cap 11 is also preferably provided for theembodiments illustrated for the embodiments illustrated in FIGS. 1A, 3,4, or other embodiments. The cap 11 fits over the top end of the device10 where the electrodes 18 a and 18 b are located. The cap 11 protectsthe electrodes 18 a and 18 b after they are cleaned (e.g., with alcoholor hydrogen peroxide) and/or when they are not in use.

FIGS. 5A and 5B are side views of another embodiment of the electricalneuromodulation stimulation device, showing an activator inserted into,and removed from, the housing 12. In this embodiment, the device 10includes a removable electrode cartridge 24, which includes the batteryand concentric electrodes 18 a and 18 b located on the contact head 26of the device 10, which is located at one end 30 of the device 10. Theremovable electrode cartridge 24 attaches into the housing 12 in such away as to be easily removed. In one embodiment it “snaps” onto thehousing using interlocking structures disposed on the electric cartridge24 and the housing 12.

FIGS. 6A and 6B are side views of another embodiment of the electricalneuromodulation stimulation device, showing a removable activatorinserted into, and removed from, the housing. The embodiment illustratedin FIGS. 6A and 6B includes a removable electrode cartridge 24 whichincludes the battery and concentric electrodes 18 a and 18 b. Theelectrodes 18 a and 18 b are disposed on the contact head 26 of thedevice 10, which is located at one end 30 of the device 10. Theremovable electrode cartridge 24 is configured to be attachable to thehousing 12 in such a way that is easily removed. In one embodiment it“snaps” onto the housing using interlocking structures on the electriccartridge 24 and the housing 12.

In the examples as illustrated in FIGS. 5A, 5B, 6A and 6B, the contacthead 26 can be flat (e.g., FIGS. 5A and 5B) or hemispherical in shape(e.g., FIGS. 6A and 6B). As illustrated in FIG. 5C, the concentricelectrodes 18 a, 18 b can be circular; alternatively, as illustrated inFIG. 6C, the electrodes 18 a, 18 b can be positioned side-by-side, eachelectrode comprising approximately half of a hemispherical surface,separated by a strip of insulating material 26 along an equatorial lineof the hemisphere.

FIG. 7 is a perspective view of yet another embodiment of an electricaltreatment device that accepts disposable heads. As illustrated in FIG.7, the device for treating viral infections comprises a housing 712. Thehousing 712 comprises an on/off button 20, an alphanumeric display 25, apower supply component 716. In one embodiment, the power supplycomponent 716 comprises a battery compartment that is adapted forreceiving at least a battery, which may be rechargeable or replaceable.In other embodiments, the power supply component comprises an AC/DCconverter for receiving an alternate current from outside of the housing712 and converting the alternate current into a direct current. Thepower supply component may also comprises an input terminal that isadapted for receiving power (e.g., DC input) from outside of the housing712. Optionally, the housing 712 may also comprise the LEDs 22 and 23 asillustrated in FIG. 1A.

Also included in the housing 712 is an electrical signal source. Theelectrical signal source is adapted for producing a series of electricalpulses on at least two output terminals. The series of electrical pulsesmay be applied to the skin or mucosa of a patient as described below. Inone embodiment, the electrical signal source comprises thelogic/processor 14 and the signal generator 17 as illustrated in FIG. 2Aor 2B. In one embodiment, the electrical signal source is configured toproduce at least one series of electric pulses that comprises ACwaveforms and at least one series of electric pulses that comprises DCwaveforms. In another embodiment, the electrical signal source isconfigured to produce electrical pulses that comprise different maximumamplitudes, and the electrical signal source may be additionallyconfigured to progressively increase or decrease in maximum voltage orcurrent amplitude of the electrical pulses. In an example, theelectrical pulses vary in maximum amplitude from approximately 3 voltsto approximately 20 volts. In yet another embodiment, the electricalsignal source is configured to produce electrical pulses that comprisedifferent frequencies, and the electrical signal source is additionallyconfigured to progressively increase or decrease in frequency of theelectrical pulses.

As illustrated in FIG. 7, the housing 712 also comprises a releasebutton 40 which is adapted for releasing a disposable head, which isdescribed below. When the treatment of a patient is completed, the usermay press the release button 40 to release the disposable head andreplace it with a new one. The release button 40 can be of any forms,shapes, or structures. In one embodiment, it comprises mechanicalclip(s), lock(s), bolt(s), hook(s), etc. In another embodiment, itcomprises an electronic component.

FIG. 7 further illustrates that the housing 712 comprises one or moreretaining holes, in the illustrated embodiment two retaining holes 746 aand 746 b. In one example, the retaining holes 746 a and 746 b areadapted for receiving corresponding attachment lugs of a disposablehead, which is described below. FIG. 7 also illustrates a cap 722, whichmay be attached to the housing 712 to protect the retaining holes 746 aand 746 b from dust or moisture when no disposable head is attached tothe housing 712.

FIGS. 8A and 8B are perspective views of one embodiment of a disposableelectrode head that may fit into the housing 712 of the electricaltreatment device as illustrated in FIG. 7. As illustrated in FIG. 8A,the disposable head 44 comprises an application surface (e.g., a surfaceof a printed circuit board 19) on a first side of the disposable head44, for application to the skin or mucosa of a patient. As illustratedin FIG. 8A, the disposable head 44 also comprises at least two embeddedelectrodes 18 a, 18 b. The embedded electrodes 18 a and 18 b are adaptedfor connecting with an electrical signal source (e.g., FIG. 2A) includedin the housing 712 (as illustrated in FIG. 7), the disposable head 44being attached to the housing 712 in a detachable manner. Each of the atleast two embedded electrodes 18 a, 18 b comprises an exposed surface onthe application surface, thus forming at least two exposed surfaces ofthe at least two embedded electrodes. Each of the at least two exposedsurfaces is separated from one another by an insulating material.Various examples of the at least two exposed surfaces of electrodes areillustrated in FIGS. 1B, 1C, 3, 4, 5C and 6C.

In one embodiment, each of the at least two exposed surfaces of theelectrodes 18 a, 18 b is in a substantially semicircular shape (e.g.,FIG. 1C, pattern 6). In other embodiments, at least one of the exposedsurfaces is configured to define a boundary surrounding at least anotherof the exposed surfaces (e.g., FIG. 1B). In some embodiments, the atleast two embedded electrodes comprise at least four embedded electrodes(e.g., FIG. 1B). In one example, the exposed surfaces of the at leasttwo embedded electrodes comprise substantially concentric contours(e.g., FIGS. 1A and 1B). In another example, the boundary is in arectangular shape (e.g., FIG. 1B). In yet other example, the boundary isin an oval shape (e.g., FIG. 1C, pattern 8). The boundary may also be ina circular shape (e.g., FIG. 4) The at least two embedded electrodes maybe configured in an a coaxial manner. The electrodes are embedded in thedisposable head 44 and exposed on the application surface. Theelectrodes are not limited to forms, shapes, structures, materials, ornumber thereof.

As illustrated in FIG. 8B, the disposable head 44 additionally comprisesat least two attachment lugs 46 a, 46 b on a second side of thedisposable head 44, adapted for connecting with the retaining holds 746a, 746 b as illustrated in FIG. 7. The attachment lugs 46 a, 46 b can beof any forms, shapes, structures, materials, or number thereof so longas the disposable head 44 can be conveniently attached to and detachedfrom the housing of the electrical signal source.

Alternatively, attachment lugs may be provided on the housing of theelectrical signal source, and retaining holes are provided in thedisposable head. The retaining holes provided in the disposable headreceive the attachment lugs provided on the housing when the disposablehead is attached to the housing of the electrical signal source. Asingle attachment lug of certain contour or shape and a single matchingretaining hole are also feasible in some other embodiments.

In one embodiment, a disposable head may be attached by inserting itsattachment lugs 46 a, 46 b, which also function as electricalconnectors, into the retaining holes 42 a, 42 b in one end of thehousing 712. After treatment of a patient, the used disposable head maybe removed from the housing 712 by pressing the release button 40 on thehousing 712. After removal of the used disposable head, a new disposablehead may be attached from a cartridge containing multiple new disposableheads.

The devices described above are used by applying the electrodes embeddedin the disposable head to the surface of the affected skin or mucosa anddelivering electrical energy to the affected area. It has been foundadvantageous for a total treatment protocol to comprise a series ofelectrical pulses, with different pulses being different in signalcharacteristics. The pulses may differ in one or more of amplitude,frequency, signal type, e.g. AC or DC, or any other electrical signalcharacteristic. It is believed that the different electrical signalcharacteristics produce different disruptive effects on the virus, thuspreventing the survival of those viruses, which may already be or whichmay become resistant to any one form of electrical stimulation orneuromodulation treatment.

FIG. 9 is a flow chart of a method for treating viral infections inaccordance with one embodiment of the invention. The flow chart asillustrated in FIG. 9 starts at block 31. At block 32, an electricalsignal pulse is applied. At decision block 34, it is determined whetheror not the pulse just applied is the last pulse of the treatment. Ifnot, the system moves to block 36, where the device is configured tooutput a pulse having characteristics different from the previous pulse.Looping back to block 32, the pulse having the new desiredcharacteristics is applied. This process continues until the last pulseof the treatment is applied, and the treatment then ends at stop block38.

In one embodiment, the method of treating viral infections comprises:attaching a disposable head to a housing of an electrical signal sourceso that at least two electrodes embedded within the disposable headrespectively connect with at least two output terminals of theelectrical signal source; placing an application surface of thedisposable head in proximate of or in contact with the skin or mucosa ofa patient; generating a series of electrical pulses by the electricalsignal source; and applying the series of electrical pulses to the skinor mucosa of the patient through the at least two electrodes; whereineach of the at least two electrodes comprises an exposed surface on theapplication surface of the disposable head.

As mentioned above, the pulses may differ in any one or more of avariety of characteristics. The pulses may change in maximum voltage orcurrent amplitude. The pulses may change between AC waveforms and DCwaveforms. AC pulses may vary in frequency or waveform such as trianglewaves, square waves, or sine waves. As described below, in someembodiments, the pulses vary in maximum amplitude from approximately 3volts to approximately 20 volts, and vary in frequency from DC to about10 kHz.

Two different specific protocols based on the principles described abovehave been devised. Protocol 1 involves ten 30 second applications ofelectrical energy, with a one hour break between each one, wherein each30 second segment is itself divided into sub-segments, which in thisembodiment may be 5, 1, and/or 0.2 second intervals. This treatmentprotocol is defined as follows:

If the ten applications are designated numbers 1 through 10,applications 1, 3, 5, 7, and 9 are as follows:

TABLE 1 5 seconds at 9 VDC 1 second each at 5, 10, 25, 50, and 75 Hz, at9 VAC peak. 5 seconds at 9 VDC 1 second each at 100, 200, 300, 400, and500 Hz, at 9 VAC peak. 5 seconds at 9 VDC 1 second each at 500, 300,100, 50, and 5 Hz, at 9 VAC peak.

Applications 2, 4, 6, 8 and 10 are as follows, all at 9 VAC peak:

TABLE 2 25 step frequency sweep from 5 Hz to 1000 Hz, 0.2 seconds ateach frequency, 9 VAC 25 step frequency sweep from 1000 Hz to 5 Hz, 0.2seconds at each frequency 25 step frequency sweep from 5 Hz to 1000 Hz,0.2 seconds at each frequency 25 step frequency sweep from 1000 Hz to 5Hz, 0.2 seconds at each frequency 25 step frequency sweep from 5 Hz to1000 Hz, 0.2 seconds at each frequency 25 step frequency sweep from 1000Hz to 5 Hz, 0.2 seconds at each frequency

In the above described protocol, the peak voltage remains constant atabout 9 V. A more complex protocol, referred to herein as Protocol 2,has also been developed which includes variation in peak voltage as wellas variations in waveform and frequency. In this specific protocol,nineteen different pulses that have been found useful and are set forthbelow in Tables 3 and 4. Twelve of the pulses are AC waveforms, andseven of the pulses are DC waveforms. Table 5 sets forth 10 differentpulse sequences, which are applied in various combinations to theaffected area during a treatment protocol.

TABLE 3 1st 2nd 3rd 4th 5th 6th 7th 8th 9th second second second secondsecond second second second second A1 5 Hz 10 Hz 25 Hz 50 Hz 75 Hz A2 25step sweep from 5 Hz to 1 kHz A3 1 kHz  2 kHz  3 kHz  4 kHz  5 kHz A4 25step sweep from 1 kHz to 5 Hz A5 5 Hz 10 Hz 25 Hz 50 Hz 75 Hz 100 Hz A61 kHz  2 kHz  3 kHz  4 kHz  5 kHz  7 kHz A7 5 Hz 10 Hz 25 Hz 50 Hz 75 Hz100 Hz 125 Hz A8 1 kHz  2 kHz  3 kHz  4 kHz  5 kHz  7 kHz  9 kHz A9 25step sweep from 10 Hz to 2.5 kHz A10 25 step sweep from 2.5 kHz to 10 HzA11 5 Hz 10 Hz 25 Hz 50 Hz 75 Hz 100 Hz 125 Hz 150 Hz 200 Hz A12 1 kHz 2 kHz  3 kHz  4 kHz  5 kHz  7 kHz  9 kHz  10 kHz

TABLE 4 1st 2nd 3rd 4th 5th 6th 7th 8th 9th 10th 11th second secondsecond second second second second second second second second D1 3 V 4V 5 V 7 V 9 V D2 3 V 4 V 5 V 7 V 9 V 11 V D3 3 V 4 V 5 V 7 V 9 V 11 V 13V D4 3 V 4 V 5 V 7 V 9 V 11 V 13 V 15 V D5 3 V 4 V 5 V 7 V 9 V 11 V 13 V15 V 17 V D6 3 V 4 V 5 V 7 V 9 V 11 V 13 V 15 V 17 V 19 V D7 3 V 4 V 5 V7 V 9 V 11 V 13 V 15 V 17 V 19 V 20 V

TABLE 5 PULSE SEQUENCE 1 A1 D1 A2 D1 A3 D1 A4 2 A1 D1 A2 D1 A3 D1 A4 A13 A1 D1 A2 D1 A3 D1 A4 D1 A1 4 A1 D1 A2 D1 A3 D1 A4 D1 A1 D1 5 A1 D2 A2D2 A3 D2 A4 D2 A1 D2 A2 6 A1 D3 A2 D3 A3 D3 A4 D3 A1 D3 A2 D3 7 A1 D4 A2D4 A3 D4 A4 D4 A1 D4 A2 D4 A3 8 A5 D5 A9 D5 A6 D5 A10 D5 A5 D5 A9 D5 A6D5 9 A7 D6 A9 D6 A8 D6 A10 D6 A7 D6 A9 D6 A8 D6 A10 10 A11 D7 A9 D7 A12D7 A10 D7 A11 D7 A9 D7 A12 D7 A10

Treatment 1

Sequence 1 at 3V

hour break

Sequence 1 at 5V

hour break

Sequence 1 at 7V

hour break

[Sequence 1 at 9V

hour break

Sequence 1 at 11V

Treatment 2

Sequence 1 through 10 at 3V

hour break

Sequence 1 through 10 at 5V

hour break

Sequence 1 through 10 at 7V

hour break

Sequence 1 through 10 at 9V

hour break

Sequence 1 through 10 at 11V

Treatment 3

Sequence 1 through 10 at 3V

hour break

Sequence 1 through 10 at 5V

hour break

Sequence 1 through 10 at 7V

hour break

Sequence 1 through 10 at 9V

hour break

Sequence 1 through 10 at 11V

hour break

Sequence 1 through 10 at 13V

hour break

Sequence 1 through 10 at 15V

hour break

Sequence 1 through 10 at 17V

hour break

Sequence 1 through 10 at 19V

hour break

Sequence 1 through 10 at 20V

Treatment 4

Sequence 1, 3V

Sequence 2, 5V

Sequence 3, 7V

Sequence 4, 9V

Sequence 5, 11V

Sequence 6, 13V

Sequence 7, 15V

Sequence 8, 17V

Sequence 9, 19V

Sequence 10, 20V

Repeat 10 times with one-hour break between each repetition.

In these treatment sequences, the peak AC and DC voltages can bespecified. Thus, in the case of the application of a DC pulse, themaximum voltage applied will be limited by either the maximum specifiedin Table 4, or by the maximum specified by the particular treatmentsegment being applied. Thus, if D7 is being applied at 7 V, the pulseapplied is one second at 3V, one second at 4V, one second at 5V, andeight seconds at 7V. However, if D7 is being applied at 20V, the pulseapplied is one second each at 3V, 4V, 5V, 7V, 9V, 11V, 13V, 15V, 17V,19V, and 20V. If D1 is applied at 20 V, the pulse is one second at 3V,one second at 4V, one second at 5V, one second at 7V, and one second at9V. All AC pulses have peak voltages as specified by the treatmentsegment being applied.

Treatment should be begun as soon as possible after the onset ofsymptoms, preferably in the prodromal stage when the characteristictingling, itching or burning sensation is felt. The distal end of thedevice is held to the affected skin or mucosa where symptoms areperceived, and treatment is commenced by pressing the “on” button. Adesignated treatment cycle of about 30 to 60 seconds is automaticallyinitiated. The LED illuminates during this on cycle.

The user generally will not feel any sensation during treatment. By theend of the 10×30 second consecutive treatments of Protocol 1, or by theend of Treatment 1 of Protocol 2, prodromal symptoms should cease. Ifsymptoms continue, or if lesions occur or are still present, it isrecommended that treatment be continued. Under protocol 1, this wouldinvolve a second course of 10 consecutive 30.second treatments. UnderProtocol 2, Treatment 2 as defined above should be administered. If,after this second course of treatments, symptoms or lesions appear orpersist, a third course of ten treatments should be carried out underProtocol 1, or Treatment 3 of Protocol 2 should be applied. Finally, ifsymptoms still remain, Protocol 2 calls for the application of Treatment4 as defined above.

It will be appreciated that a wide variety of treatment protocols couldbe devised based on the principles of the invention, and that the twodescribed above are only two specific examples of treatment protocolswith the advantageous feature of pulse variability.

A number of device electrode placement protocols can be employed withthe present invention and these involve various anatomical sites.Electrode placement sites may be in relationship to neural ganglia whereviruses establish residence. For example, the trigeminal ganglion nearthe ear is a site where HSV-1 (herpes labialis) establishes residence,from which it recurs on the lower lip or face. Therefore this site isideal for electrode placement and is located in front of the ear(external auditory meatus), below the zygomatic arch, and over theposition of the facial nerve and parotid gland. Another neural ganglionexample for electrode placement is the sacral ganglion at the base ofthe spine. This is where HSV-2 (genital herpes) sets up residence fromwhich it recurs in the genital area.

Other electrode placement sites can be in relationship to regional lymphnodes. Examples of these sites would be in the cervical chain of lymphnodes positioned bilaterally at the front of the neck, lymph nodes inthe tonsil bed positioned just under the angle of the jaw (junction ofhorizontal ramus and ascending ramus of mandible), in the auxiliarychain of lymph nodes positioned under the arms, and in the inguinallymph nodes positioned bilaterally in the groin.

Further sites for electrode placement can be in relationship to airsinuses such as those in the facial bones of the skull. Examples includethe maxillary antrum, each positioned below the eyes and above the upperteeth, accessed by placement either side of the nose level with theeyes, and the frontal sinus positioned either side of the midline on theforehead just above the eyes.

With the treatment of viral diseases that affect the whole body, and forserious and life threatening viral diseases such as AIDS, it will benecessary to carry out treatments using placements of the electricaldevice in other additional anatomical regions using a consecutivepattern of treatments.

In one such protocol, the device is used consecutively on threedifferent anatomical regions of the body. These three sites are referredto collectively as “The Central Location.” In this, the first placementsite is in the center of the spine, slightly above the level of theshoulders, which is the position of cervical vertebra #7, referred to asC7. The second site is also positioned longitudinally in the center ofthe spine but between the neck and the base of the spine, which is atabout thoracic vertebra #7 (T7). The third and last position is also inthe center of the spine but positioned at the base of the lumbar spineequivalent with the 5th lumbar vertebra, referred to as L5.

In another protocol, a further seven anatomical placement sites areemployed in addition to the above three sites of The Central Location.Whereas the three previous sites are on the back, or dorsal position, ofthe body, the seven additional sites are located on the front, orventral position, of the body. These seven different anatomical regionsof the body coincide with the seven “chakras” and channels of energy.Many workers have contemplated that in addition to a network of nervesand sensory organs, there also exists a subtle system of channels andcenters of energy (chakras), which affect the physical, intellectual,emotional and spiritual being. These seven regions are used as electrodeplacement sites and are positioned in seven specific regions of the bodyranging from the crown to the sternum, including regions such as theheart. The seven regions are generally referred to as the crown, root,sacral, solar plexus, heart, throat, and third eye chakras. These sevenlocations physically correspond to the locations of the top of the head,between the anus and the genitals, between the navel and the genitals,between the navel and the base of the sternum, in the center of thechest, centrally at the base of the throat, and above and between theeyebrows respectively.

In these two other protocol examples of treating viral infections of theentire body, the treatment sequences shown in Table 5, and in Treatment4, are employed whereby ten different pulse sequences are applied invarious combinations. Each of the ten separate outputs ramp upconsecutively through the various voltage levels resulting in a totaltreatment time of eight minutes and forty-five seconds in eachanatomical site. This regimen may be carried out on each of either thethree regions in The Central Location or, additionally, the seven chakraregions as described above, making ten anatomical sites in all.

The three Central Location sites would give a total treatment time of3×8 minutes and 45 seconds, which is 26 minutes and 15 seconds. Theseven chakra regions would give a total treatment time of sixty-oneminutes and fifteen seconds. Treatment of all ten locations would give atotal treatment time of 87 minutes and thirty seconds. The entiresequence would then be repeated according to the protocol employed whichcould be, for example, nine repetitions, which is ten treatments in all.

Use of a neuromodulation stimulation device in the treatment of variousforms of viral infections are further described in the followingspecific examples.

EXAMPLE 1 Oral Herpes

A female subject, date of birth Mar. 15, 1975, had a twelve year historyof oral herpes infections. Outbreaks tended to occur at the lip borders,especially the lower lip, and were more frequent during cold weather andduring times of stress. She reported approximately four to six outbreaksper year, each lasting about 10-14 days. Previous treatments had beenunsuccessful.

The subject was given an electrical neuromodulation device as describedabove that was configured to apply Protocol 1 as described above. Shewas instructed to apply the device directly to the infected area orareas, and apply the ten 30 second treatments as described in Protocol 1above, with a one hour break between each 30 second treatment. Thedevice was configured to automatically step through the ten differentelectrical pulses as shown above as the subject applied the device forthe ten consecutive 30 second periods. Thus, the subject only had toplace the electrodes on the affected area, press the ON button, and waitfor an LED display to turn off after 30 seconds.

After the first treatment, the subject reported that the small vesiclesthat had begun to develop started to dry up immediately after treatment.The small reddish areas indicating the onset of an outbreak disappearedcompletely within three days, as did any symptoms of burning or itching.

EXAMPLE 2 Recurrent Genital Herpes

The male subject, date of birth Dec. 25, 1955, had a history of genitalherpes for the past 20 plus years. The outbreaks always occurred on hispenis and varied from minor outbreaks to major ones. The subjectreported that he had four to five outbreaks on average each year. Healso reported that in his opinion, they often occurred in relation tostress and when he was working very hard physically.

The subject had an outbreak, which was preceded by prodrome earlywarning symptoms. The subject reported that his thighs began to tingleand feel “funny”, which is what usually happened just before anoutbreak. The day following the prodrome symptoms, the subject noticed asmall raised red lump on the top of the head of his penis. The subjectstarted treatment with the device of the present invention on the redspot once every hour for a total of ten treatments using Protocol 1 asdescribed above and as in Example 1. The subject reported that the redspot did not get any larger like it usually did, and was not painful,which was atypical since it usually was very painful by the second day.The subject reported that the red spot did not progress to the blisterstage. This was the first time in his twenty plus year history of havinggenital herpes that an outbreak did not progress to a blister stage. Thesubject also reported that there was no release of fluid, which was alsounusual. The outbreak dried up and disappeared completely after thethird day.

The subject had another prodrome stage where the symptoms were similarto those described previously; his thighs started to tingle and burn.The subject noticed that a small outbreak had developed on the undersideof his penis and appeared as a raised red spot. This became larger andthe subject reported that this had all of the signs of being one of hismajor outbreaks that he got regularly about once a year. The subjectstarted using the device for treatment as soon as he noticed theoutbreak. He used the device every hour as instructed, positioning thetip of the device on the red raised lesion, in the same manner asdescribed above. The lesion did not get any larger once treatmentstarted. The subject reported that after the appearance of the red spotand commencement of treatment, there was no formation of blisters, nowetness or oozing of fluid, and no pain. The subject reported that theoutbreak started to resolve itself the day after commencing treatmentwith the device.

Seven months later, the subject reported that he noticed a little redcolored spot appear on the upper side of his penis, which swelled anddeveloped into a small bump. The subject reported that there were nosigns of a prodrome stage this time. He used the viral device with thesame treatment regimen of once an hour, and during treatments, the smallbump did not get any larger, and disappeared after a couple of days. Thesubject reported that this was the “best” outbreak he had in the lasttwenty years because there was no pain, no swelling, and no discharge,and it was all over in a couple of days.

Three months later, the subject reported that he had a very smalloutbreak on the left rear thigh. It appeared as a small red spot butthere was no evidence of any lesion on his penis. He used the viraldevice on top of the lesion employing the same protocol as describedabove, and the small lesion did not get any bigger. The subject reportedthat there was no blistering, no discharge and no pain. The outbreakcleared up completely in a couple of days.

Five months later, the subject reported the appearance of a small redswelling on the side of his penis. As soon as he saw evidence of theoutbreak he started treatment with the device using the once-an-hourprotocol described above. The lesion did not progress in size, did notblister, and was not painful. It responded well to the treatment and thelesion disappeared by day three.

EXAMPLE 3 Human Papiloma Virus

A female subject, date of birth Jun. 21, 1951, had a history of lesionsappearing on the lower part of her legs, generally on the front aspectbetween the knee and the ankle. An outbreak usually consisted of 2-3 tosix or more lesions, and tended to occur during times of stress. Thelesions would become larger over a period of five to seven days, andwould dry up and disappear two to three weeks after their appearance.The lesions were diagnosed as being caused by Human Papiloma Virus, forwhich oral medication and topical cream was prescribed. These treatmentswere not successful.

The subject then tried the electrical neuromodulation stimulation deviceof the present invention, using it directly on the lesions for ten 30second treatments as described above in Examples 1 and 2. She treatedeach lesion separately, unless two were very close together, in whichcase the electrodes were placed between the two lesions.

The subject reported that the pain subsided immediately, and that thelesions healed and disappeared within three days.

EXAMPLE 4 Verruca

A male subject, date of birth May 28, 1949, developed a verruca wart onthe sole of his right foot. The lesion was positioned at the front andin the center of the planter surface of the foot immediately to the sideof the large toe prominence. It interfered with the subject's walkingand running. The subject had tried a number of treatments, including 40%salicylic acid pads, but these did not eliminate the wart or theassociated pain and discomfort.

The subject used the neuromodulation stimulation device described abovefor ten 30 second treatments as in Examples 1-3. After the tentreatments, the subject reported that the pain had stopped completely.The lesion was still visible as a raised area on the planter surface ofthe foot, and a second series of ten treatments was applied, commencingabout one hour after the conclusion of the first series of tentreatments. By the end of the second course of treatment, the lesionappeared different in texture, was less swollen, and was not painful.The subject was advised to foot file the region, which he did, afterwhich the affected area looked normal.

Follow up with the subject over nine months following treatment revealedthat he was completely pain free, with no evidence that the verruca hadreturned.

Thus, the method and device described herein were found to be effectivein the treatment of viral infection. The treatment with the device notonly improved recovery time, but also reduced the frequency ofrecurrence.

INDUSTRIAL APPLICABILITY

The above-described electrical stimulation is sometimes referred toherein as “neurostimulation” or “noninvasive therapeuticneuromodulation.” The devices and methods as described above andequivalent devices and methods can be used for treating viral infectionsby using electrical neuromodulation stimulation. Disposable heads, asdescribed herein, can be used for different patients, different sessionsof treatment, or different viral infections.

The foregoing description details certain embodiments of the invention.It will be appreciated, however, that no matter how detailed theforegoing appears in text, the invention can be practiced in many ways.As is also stated above, it should be noted that the use of particularterminology when describing certain features or aspects of the inventionshould not be taken to imply that the terminology is being re-definedherein to be restricted to including any specific characteristics of thefeatures or aspects of the invention with which that terminology isassociated. The scope of the invention should therefore be construed inaccordance with the appended claims and any equivalents thereof.

1. A device for treating viral infections comprising: a housing; a powersupply component disposed in the housing; an electrical signal sourcedisposed in the housing and comprising at least two output terminals,the signal source configured for producing a series of electrical pulseson the at least two output terminals under a condition that power issupplied from the power supply component to the electrical signalsource; and a disposable head adapted for connecting with the housing ina detachable manner, disposable head comprising at least two embeddedelectrodes adapted for respectively connecting with the at least twooutput terminals of the electrical signal source, subsequent to thedisposable head being connected with the housing.
 2. The device of claim1, wherein each of the at least two embedded electrodes comprises anexposed surface being separated from one another by an insulatingmaterial.
 3. The device of claim 2, wherein each of the at least twoexposed surfaces is configured in a substantially semicircular shape. 4.The device of claim 2, wherein at least one of the exposed surfacesbeing configured to define a boundary surrounding at least another ofthe exposed surfaces.
 5. The device of claim 4, wherein the at least twoembedded electrodes comprise at least four embedded electrodes.
 6. Thedevice of claim 4, wherein the exposed surfaces of the at least twoembedded electrodes comprise substantially concentric contours.
 7. Thedevice of claim 4, wherein the boundary is rectangular in shape.
 8. Thedevice of claim 4, wherein the boundary is oval in shape.
 9. The deviceof claim 4, wherein the boundary is circular in shape.
 10. The device ofclaim 1, wherein the at least two embedded electrodes are configured inan a coaxial manner.
 11. The device of claim 1, wherein the disposablehead additionally comprises a connecting mechanism for attaching withthe housing.
 12. The device of claim 11, wherein the connectingmechanism comprises at least one attachment lug, and wherein the housingcomprises at least one retaining hole for receiving the at least oneattachment lug.
 13. The device of claim 1, wherein the housing comprisesa release button adapted for releasing the disposable head.
 14. Thedevice of claim 1, wherein the power supply component comprises abattery compartment adapted for receiving a battery.
 15. The device ofclaim 1, wherein the power supply component comprises an AC/DCconverter.
 16. The device of claim 1, wherein the power supply componentcomprises an input terminal adapted for receiving power from outside ofthe housing.
 17. The device of claim 1, wherein the electrical signalsource is additionally configured to progressively increase or decreasein maximum voltage or current amplitude of the electrical pulses. 18.The device of claim 1, wherein the electrical pulses vary in maximumamplitude from approximately 3 volts to approximately 20 volts.
 19. Thedevice of claim 1, wherein the electrical signal source is configured toproduce electrical pulses that comprise different frequencies.
 20. Thedevice of claim 19, wherein the electrical signal source is additionallyconfigured to progressively increase or decrease in frequency of theelectrical pulses.
 21. A disposable head comprising: an applicationsurface on a first side of the disposable head, for application to theskin or mucosa of a patient; and at least two embedded electrodesadapted for connecting with an electrical signal source, the disposablehead being attached to the electrical signal source in a detachablemanner; wherein each of the at least two embedded electrodes comprisesan exposed surface on the application surface, forming at least twoexposed surfaces of the at least two embedded electrodes, each of the atleast two exposed surfaces being separated from one another by aninsulating material.
 22. The disposable head of claim 21, furthercomprising a connecting mechanism for connecting with the electricalsignal source.
 23. The disposable head of claim 22, wherein theconnecting mechanism comprises at least one attachment lug on a secondside of the disposable head, adapted for connecting with at least oneretaining hold provided on a housing of the electrical signal source.24. The disposable head of claim 21, wherein each of the at least twoexposed surfaces is in a substantially semicircular shape.
 25. Thedisposable head of claim 21, wherein at least one of the at least twoexposed surfaces is in a substantially semicircular shape.
 26. Thedisposable head of claim 21, wherein at least one of the exposedsurfaces being configured to define a boundary surrounding at leastanother of the exposed surfaces.
 27. The disposable head of claim 21,wherein the at least two embedded electrodes comprise at least fourembedded electrodes.
 28. The disposable head of claim 21, wherein theexposed surfaces of the at least two embedded electrodes comprisesubstantially concentric contours.
 29. The disposable head of claim 26,wherein the boundary is in a rectangular shape.
 30. The disposable headof claim 26, wherein the boundary is in an oval shape.
 31. Thedisposable head of claim 26, wherein the boundary is in a circularshape.
 32. The disposable head of claim 26, wherein the at least twoembedded electrodes are configured in an a coaxial manner.
 33. A methodof treating viral infections comprising: attaching a disposable head toa housing of an electrical signal source so that at least two electrodeswithin the disposable head respectively connect with at least two outputterminals of the electrical signal source; placing an applicationsurface of the disposable head in contact with the skin or mucosa of apatient, wherein each of the at least two electrodes comprises anexposed surface on the application surface of the disposable head;generating a series of electrical pulses by the electrical signalsource; and applying the series of electrical pulses to the skin ormucosa of the patient through the at least two electrodes,